FDA applicant
Xuzhou Kernel Medical Equipment Co., Ltd.
FDA records 9 decisions for Xuzhou Kernel Medical Equipment Co., Ltd. (Xuzhou, CN) from 2014 to 2026: 9 510(k) clearances. Most are in product codes FTC (Light, Ultraviolet, Dermatological) and OAP (Laser, Comb, Hair). Since 2016 its 510(k)s took a median of 138 days from receipt to decision, against 89 for FDA’s reviews in the same codes and years. Its devices cite 16 predicates, 2 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Xuzhou Kernel Medical Equipment Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2014.
Planning a device like Xuzhou Kernel Medical Equipment Co.…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Xuzhou”
FDA records each applicant name separately; these may or may not be the same firm.